How to launch your Medical Device

Manufacturers looking to launch their medical device within the European Union (EU) need to comply with the relevant EU medical device regulations.

The first step in the process is for manufacturers to classify their medical device based on the requirements in the new Medical Device Regulation (MDR).

Then, based on the classification of the device, manufacturers can identify the appropriate conformity assessment route for their product. This route will determine the required activities manufacturers will need to comply with in order to receive a CE marking.

LRQA’s guide to the MDR Conformity Assessment Procedures will help you understand the different routes to compliance, and which route applies to your medical device.

News

In general, we view an exit from the EU as unlikely to have a significant short-term impact on how LR provides services to clients. However, given the extent of the uncertainty about how the process will unfold, we will continue to follow events and keep our clients updated on our view and plans.

Following an extensive audit by the United Kingdom Accreditation Service (UKAS), LRQA has been granted accreditation to ISO 13485:2016, the international quality management system (QMS) standard for organizations involved in medical device manufacturing.

LRQA’s role as an EU Notified Body will not change following the recent decision of the EU referendum while the UK Government sets out the arrangements for its withdrawal from the EU. During this transition period, LRQA will be working closely with the Medicines and Healthcare products Regulatory Agency (MHRA) so that LRQA remains as an EU recognized Notified Body for Medical Devices post the UK leaving the EU.

Events

This annual event hosts the global regulatory community and brings together the profession’s best and brightest to learn, grow, lead and share. Find out what the IVDR & MDR Regulations mean to your organization - LRQA presents the top frequently asked questions.

The new EU IVDR will replace and repeal the existing IVD Directive 98/79/EC when it is published, currently expected during the second quarter of 2017. With the aim of tightening and strengthening the approval system for IVDs, the new regulation introduces a number of important changes